Core Viewpoint - Unicycive Therapeutics has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to the FDA, with a new PDUFA date expected in the first half of 2026, following progress in resolving compliance issues with its manufacturing vendor [1][2]. Group 1: Company Developments - The resubmission of the NDA was made possible due to significant progress by the original third-party manufacturing vendor in regaining FDA compliance [2]. - The company has a cash runway extending into 2027, positioning it well to complete the regulatory approval process for OLC [2]. - The NDA submission package includes data from three clinical studies and is supported by a strong global patent portfolio, with exclusivity until 2031 and potential extension until 2035 [5]. Group 2: Product Information - OLC is an investigational oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, utilizing proprietary nanoparticle technology for enhanced phosphate binding potency [4]. - The treatment aims to reduce the pill burden for patients, potentially improving adherence compared to existing options [4]. Group 3: Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [6]. - Effective treatment of hyperphosphatemia is essential as uncontrolled levels are linked to increased mortality and hospitalization among CKD patients on dialysis [6].

Core Insights - Unicycive Therapeutics is advancing its lead investigational treatment, oxylanthanum carbonate (OLC), for patients with hyperphosphatemia and plans to resubmit the New Drug Application (NDA) by the end of 2025 following positive discussions with the FDA [2][8] - The company reported a net loss of $6.0 million for the quarter ended September 30, 2025, an increase from a net loss of $4.1 million in the same period of 2024, primarily due to increased labor and professional services costs [6][9] - Unicycive ended Q3 2025 with $42.7 million in cash, providing a runway into 2027, which positions the company well for regulatory approval and potential product launch [7][9] Financial Results - Research and Development (R&D) expenses for Q3 2025 were $3.0 million, a slight decrease from approximately $3.1 million in Q3 2024, attributed to reduced professional services and drug development costs [4] - General and Administrative (G&A) expenses increased to $4.4 million in Q3 2025 from $3.2 million in Q3 2024, mainly due to higher labor and consulting costs [5] - Other income decreased to $1.3 million in Q3 2025 from $2.2 million in Q3 2024, primarily due to changes in the fair value of warrant liability [6] Upcoming Milestones - The company is on track to resubmit the NDA for OLC by year-end 2025, with a potential new Prescription Drug User Fee Act (PDUFA) date in the first half of 2026 [8] - New data presented at the ASN Kidney Week 2025 indicates that OLC significantly reduces pill burden, with a 7-fold decrease in pill volume and a 2-fold reduction in pill count compared to existing phosphate binders [2][8]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Unicycive Therapeutics, Inc. due to a class action complaint alleging breaches of fiduciary duties by the company's board of directors during the specified class period [2]. Group 1: Legal Investigation - The investigation is focused on long-term stockholders of Unicycive between March 29, 2024, and June 27, 2025, following a class action complaint filed on August 15, 2025 [2][4]. - Investors are encouraged to contact the law firm for discussions regarding their legal rights and options [1][4]. Group 2: Company Performance and Regulatory Issues - The complaint alleges that Unicycive misrepresented its readiness to meet FDA manufacturing compliance requirements for its New Drug Application (NDA) for oxylanthanum carbonate (OLC) [8]. - On June 10, 2025, Unicycive disclosed that the FDA identified deficiencies in current good manufacturing practice (cGMP) compliance at a third-party vendor, leading to a significant stock price drop of over 40% [8]. - Following the issuance of a Complete Response Letter from the FDA on June 30, 2025, citing the same deficiencies, Unicycive's stock fell nearly 30%, closing at $4.77 per share [8].

Core Insights - Unicycive Therapeutics is presenting new data on oxylanthanum carbonate (OLC) at the ASN Kidney Week 2025, highlighting significant reductions in pill burden for patients with chronic kidney disease (CKD) [1][2] Group 1: Study Findings - The open-label trial showed a 7-fold reduction in pill volume and a 2-fold reduction in pill count compared to pre-trial phosphate binder therapy [1][2] - The mean daily pill volume decreased from 9.3 cm to 1.4 cm, and the average number of pills taken daily dropped from 8.3 to 3.9 [6] - At the end of the OLC titration period, 91% of patients had serum phosphate levels ≤5.5 mg/dL, up from 59% at screening [6] Group 2: Product Information - OLC is an investigational oral phosphate binder utilizing proprietary nanoparticle technology, aimed at improving patient adherence by reducing the number and size of pills [8] - The company is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway, supported by data from three clinical studies and a strong patent portfolio [9] Group 3: Industry Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication for phosphate control annually [10] - Effective treatment of hyperphosphatemia is essential to reduce associated risks of increased mortality and hospitalization in CKD patients on dialysis [10]

Core Points - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged misrepresentation regarding its New Drug Application for oxylanthanum carbonate [8] - The lawsuit covers investors who purchased Unicycive securities between March 29, 2024, and June 27, 2025, with a deadline of October 14, 2025, to apply as lead plaintiff [8] - The complaint alleges that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements, which led to significant stock price declines following negative FDA inspections [8] Allegation Details - The lawsuit claims that Unicycive assured investors of its ability to satisfy FDA requirements but failed to disclose deficiencies identified by the FDA at a third-party manufacturing vendor [8] - Following the announcement of these deficiencies on June 10, 2025, Unicycive's stock price fell over 40% [8] - On June 30, 2025, the FDA issued a Complete Response Letter for the NDA, resulting in a further stock price drop of nearly 30%, closing at $4.77 per share [8] Next Steps - Investors who suffered losses and wish to discuss their legal rights are encouraged to contact Bragar Eagel & Squire, P.C. for more information [4] - The law firm offers no cost or obligation for consultations regarding the lawsuit [4]

Core Points - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged misrepresentation regarding its New Drug Application for oxylanthanum carbonate [8] - The lawsuit covers investors who purchased Unicycive securities between March 29, 2024, and June 27, 2025, with a deadline of October 14, 2025, to apply as lead plaintiff [8] - The complaint claims that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements, which led to significant stock price declines following negative FDA inspections [8] Allegation Details - The lawsuit alleges that Unicycive's management assured investors of the company's ability to satisfy FDA requirements, which was later revealed to be overstated [8] - On June 10, 2025, Unicycive disclosed that the FDA identified deficiencies in compliance at a third-party manufacturing vendor, leading to a stock price drop of over 40% [8] - Following a Complete Response Letter from the FDA on June 30, 2025, citing the same deficiencies, Unicycive's stock fell nearly 30%, closing at $4.77 per share [8] Next Steps - Investors who suffered losses and wish to discuss their legal rights are encouraged to contact the law firm Bragar Eagel & Squire, P.C. for more information [4] - The firm emphasizes that there is no cost or obligation for investors to inquire about their rights [4]

Core Points - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged misrepresentation regarding its New Drug Application for oxylanthanum carbonate [8] - The lawsuit covers investors who purchased Unicycive securities between March 29, 2024, and June 27, 2025, with a deadline of October 14, 2025, to apply as lead plaintiff [8] - The complaint claims that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements, which led to significant stock price declines following negative FDA inspections [8] Allegation Details - The lawsuit alleges that Unicycive's management assured investors of the company's ability to satisfy FDA requirements, which was later revealed to be overstated [8] - On June 10, 2025, Unicycive disclosed deficiencies in cGMP compliance at a third-party vendor, leading to a stock price drop of over 40% [8] - Following a Complete Response Letter from the FDA on June 30, 2025, citing the same deficiencies, Unicycive's stock fell nearly 30%, closing at $4.77 per share [8] Next Steps - Investors who suffered losses and wish to discuss their legal rights are encouraged to contact Bragar Eagel & Squire, P.C. for more information [4] - The law firm emphasizes that there is no cost or obligation for investors to inquire about their rights [4]

Core Points - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged misrepresentations regarding its New Drug Application for oxylanthanum carbonate [7] - The lawsuit covers investors who purchased Unicycive securities between March 29, 2024, and June 27, 2025, with a deadline of October 14, 2025, to apply as lead plaintiff [7] - The complaint alleges that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements, which led to significant stock price declines following negative FDA inspections [7] Allegation Details - The lawsuit claims that Unicycive assured investors of its ability to satisfy FDA requirements but failed to disclose deficiencies identified by the FDA at a third-party manufacturing vendor [7] - Following the announcement of these deficiencies on June 10, 2025, Unicycive's stock price fell over 40% [7] - On June 30, 2025, the FDA issued a Complete Response Letter for the NDA, resulting in a further stock price decline of almost 30%, closing at $4.77 per share [7] Next Steps - Investors who suffered losses and wish to discuss their legal rights are encouraged to contact Bragar Eagel & Squire, P.C. for more information [4][8] - The law firm represents individual and institutional investors in complex litigation across the United States [5]

Core Points - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged misrepresentation regarding its New Drug Application for oxylanthanum carbonate [8] - The lawsuit covers investors who purchased Unicycive securities between March 29, 2024, and June 27, 2025, with a deadline of October 14, 2025, to apply as lead plaintiff [8] - The complaint alleges that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements, which led to significant stock price declines following negative FDA inspections [8] Allegation Details - The lawsuit claims that Unicycive assured investors of its ability to satisfy FDA requirements but failed to disclose deficiencies identified by the FDA at a third-party manufacturing vendor [8] - Following the announcement of these deficiencies on June 10, 2025, Unicycive's stock price fell over 40% [8] - A subsequent Complete Response Letter from the FDA on June 30, 2025, citing the same deficiencies, caused the stock to drop nearly 30%, closing at $4.77 per share [8] Next Steps - Investors who suffered losses and wish to discuss their legal rights are encouraged to contact the law firm Bragar Eagel & Squire, P.C. for more information [4][5] - The firm emphasizes that there is no cost or obligation for investors to inquire about their rights [4]

Core Points - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged misrepresentation regarding its New Drug Application for oxylanthanum carbonate [8] - The lawsuit covers all individuals and entities that purchased Unicycive securities between March 29, 2024, and June 27, 2025, with a deadline of October 14, 2025, to apply as lead plaintiff [8] - The complaint alleges that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements, which led to significant stock price declines following negative FDA inspections [8] Allegation Details - The lawsuit claims that Unicycive assured investors of its ability to satisfy FDA requirements but failed to disclose deficiencies identified by the FDA at a third-party manufacturing vendor [8] - Following the announcement of these deficiencies on June 10, 2025, Unicycive's stock price fell over 40% [8] - On June 30, 2025, the FDA issued a Complete Response Letter for the NDA, resulting in a further stock price decline of almost 30%, closing at $4.77 per share [8] Next Steps - Investors who suffered losses and wish to discuss their legal rights are encouraged to contact Bragar Eagel & Squire, P.C. for more information [4] - The law firm represents both individual and institutional investors in complex litigation across various courts [5]